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FDA 510(k) Application Details - K191208
Device Classification Name
Pump, Breast, Powered
More FDA Info for this Device
510(K) Number
K191208
Device Name
Pump, Breast, Powered
Applicant
Uzinmedicare Co.
56, Dongtansandan 5-Gil, Dongtan-Myeon
Hwaseong-Si 18487 KR
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Contact
Nathan Ahn
Other 510(k) Applications for this Contact
Regulation Number
884.5160
More FDA Info for this Regulation Number
Classification Product Code
HGX
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More FDA Info for this Product Code
Date Received
05/06/2019
Decision Date
10/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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